[Catbert]

http://harpers.org/OutOfControl.html

Out of Control
AIDS and the corruption of medical science
Posted on Friday, April 7, 2006. Originally from Harper's Magazine, March 2006. By Celia Farber.
Sources

Joyce Ann Hafford was a single mother living alone with her thirteen-year-old son, Jermal, in Memphis, Tennessee, when she learned that she was pregnant with her second child. She worked as a customer service representative at a company called CMC Call Center; her son was a top student, an athlete and musician. In April 2003, Hafford, four months pregnant, was urged by her obstetrician to take an HIV test. She agreed, even though she was healthy and had no reason to think she might be HIV positive. The test result came up positive, though Hafford was tested only once, and she did not know that pregnancy itself can cause a false positive HIV test. Her first thought was of her unborn baby. Hafford was immediately referred to an HIV/AIDS specialist, Dr. Edwin Thorpe, who happened to be one of the principal investigators recruiting patients for a clinical trial at the University of Tennessee Medical Group that was sponsored by the Division of AIDS (DAIDS)—the chief branch of HIV/AIDS research within the National Institutes of Health.

The objective of the trial, PACTG 1022, was to compare the “treatment-limiting toxicities” of two anti-HIV drug regimens. The core drugs being compared were nelfinavir (trade name Viracept) and nevirapine (trade name Viramune). To that regimen, in each arm, two more drugs were added—zidovudine (AZT) and lamivudine (Epivir) in a branded combination called Combivir. PACTG 1022 was a “safety” trial as well as an efficacy trial, which means that pregnant women were being used as research subjects to investigate “safety” and yet the trial was probing the outer limits of bearable toxicity. Given the reigning beliefs about HIV’s pathogenicity, such trials are fairly commonplace, especially in the post-1994 era, when AZT was hailed for cutting transmission rates from mother to child.

The goal of PACTG 1022 was to recruit at least 440 pregnant women across the nation, of which 15 were to be enrolled in the University of Tennessee Medical Group. The plan was to assign the study’s participants to one of two groups, with each receiving three HIV drugs, starting as early as ten weeks of gestation. Of the four drugs in this study, three belong to the FDA’s category “C,” which means that safety to either mother or fetus has not been adequately established.

Joyce Ann Hafford was thirty-three years old and had always been healthy. She showed no signs of any of the clinical markers associated with AIDS—her CD4 counts, which measure the lymphocytes that are used to indicate how strong a person’s immune system is, and which HIV is believed to slowly corrode, were in the normal range, and she felt fine. In early June 2003, she was enrolled in the trial and on June 18 took her first doses of the drugs. “She felt very sick right away,” recalls her older sister, Rubbie King. “Within seventy-two hours, she had a very bad rash, welts all over her face, hands, and arms. That was the first sign that there was a problem. I told her to call her doctor and she did, but they just told her to put hydrocortisone cream on it. I later learned that a rash is a very bad sign, but they didn’t seem alarmed at all.”

Hafford was on the drug regimen for thirty-eight days. “Her health started to deteriorate from the moment she went on the drugs,” says King. “She was always in pain, constantly throwing up, and finally she got to the point where all she could do was lie down.” The sisters kept the news of Hafford’s HIV test and of the trial itself from their mother, and Hafford herself attributed her sickness and nausea to being pregnant. She was a cheerful person, a non-complainer, and was convinced that she was lucky to have gotten into this trial. “She said to me, ‘Nell’ —that’s what she called me—‘I have got to get through this. I can’t let my baby get this virus.’ I said, ‘Well, I understand that, but you’re awful sick.’ But she never expressed any fear because she thought this was going to keep her baby from being HIV positive. She didn’t even know she was in trouble.”

On July 16, at her scheduled exam, Hafford’s doctor took note of the rash, which was “pruritic and macular-papular,” and also noted that she was suffering hyperpigmentation, as well as ongoing nausea, pain, and vomiting. By this time all she could keep down were cans of Ensure. Her blood was drawn for lab tests, but she was not taken off the study drugs, according to legal documents and internal NIH memos.

Eight days later, Hafford went to the Regional Medical Center “fully symptomatic,” with what legal documents characterize as including: “yellow eyes, thirst, darkening of her arms, tiredness, and nausea without vomiting.” She also had a rapid heartbeat and difficulty breathing. Labs were drawn, and she was sent home, still on the drugs. The next day, July 25, Hafford was summoned back to the hospital after her lab reports from nine days earlier were finally reviewed. She was admitted to the hospital’s ICU with “acute and sub-acute necrosis of the liver, secondary to drug toxicity, acute renal failure, anemia, septicemia, premature separation of the placenta,” and threatened “premature labor.” She was finally taken off the drugs but was already losing consciousness. Hafford’s baby, Sterling, was delivered by C-section on July 29, and she remained conscious long enough not to hold him but at least to see him and learn that she’d had a boy. “We joked about it a little, when she was still coming in and out of consciousness in ICU,” Rubbie recalls. “I said to her, ‘You talked about me so much when you were pregnant that that baby looks just like me.’” Hafford’s last words were a request to be put on a breathing tube. “She said she thought a breathing tube might help her,” says Rubbie. “That was the last conversation I had with my sister.” In the early morning hours of August 1, Rubbie and her mother got a call to come to the hospital, because doctors had lost Hafford’s pulse. Jermal was sleeping, and Rubbie woke her own daughter and instructed her not to tell Jermal anything yet. They went to the hospital, and had been there about ten minutes when Joyce Ann died.

* * *

Rubbie recalls that the hospital staff said they would clean her up and then let them sit with her. She also remembered a doctor who asked for their home phone numbers and muttered, “You got a lawsuit.” (That person has not resurfaced.) They hadn’t been sitting with Hafford’s body long when a hospital official came in and asked the family whether they wanted an autopsy performed. “We said yes, we sure do,” she says. The hospital official said it would have to be at their expense—at a cost of $3,000. “We said, ‘We don’t have $3,000.’ My sister didn’t have any life insurance or anything,” says Rubbie. “She had state health care coverage, and we were already worried about how to get the money together to bury her.” Consequently, no autopsy was done. There was a liver biopsy, however, which revealed, according to internal communiqués of DAIDS staff, that Hafford had died of liver failure brought on by nevirapine toxicity.

And what was the family told about the cause of Hafford’s death?

“How did they put it?” Rubbie answers, carefully. “They told us how safe the drug was, they never attributed her death to the drug itself, at all. They said that her disease, AIDS, must have progressed rapidly.” But Joyce Ann Hafford never had AIDS, or anything even on the diagnostic scale of AIDS. “I told my mom when we were walking out of there that morning,” Rubbie recalls, “I said, ‘Something is wrong.’ She said, ‘What do you mean?’ I said, ‘On the one hand they’re telling us this drug is so safe, on the other hand they’re telling us they’re going to monitor the other patients more closely. If her disease was progressing, they could have changed the medication.’ I knew something was wrong with their story, but I just could not put my finger on what it was.”

more at the link.
****ing sick ****s

[Catbert]

Too tragic?

[Jelena]

That´s a sad story.

[Melanie68]

This is from the CDC.

What blood tests detect the presence of HIV?

HIV testing consists of an initial screening with two types of tests commonly used to detect HIV infection. The most commonly used initial test is an enzyme immune assay (EIA) or the enzyme-linked immunosorbent assay (ELISA). If EIA test results show a reaction, the test is repeated on the same blood sample. If the sample is repeatedly the same result or either duplicate test is reactive, the results are "confirmed" using a second test such as the Western blot. This more specific (and more expensive) test can tell the difference between HIV antibodies and other antibodies that can react to the EIA and cause false positive results. False positive EIA results are uncommon, but can occur. A person is considered infected following a repeatedly reactive result from the EIA, confirmed by the Western blot test.

In addition to the EIA or ELISA and Western blot, other tests now available include:

* Radioimmunoprecipitation assay (RIPA): A confirmatory blood test that may be used when antibody levels are very low or difficult to detect, or when Western blot test results are uncertain. An expensive test, the RIPA requires time and expertise to perform.
* Dot-blot immunobinding assay: A rapid-screening blood test that is cost-effective and that may become an alternative to standard EIA and Western blot testing.
* Immunoflourescence assay: A less commonly used confirmatory blood test used on reactive ELISA samples or when Western blot test results are uncertain.
* Nucleic acid testing (e.g., viral RNA or proviral DNA amplification method): A less available blood test that can be used to resolve an initial indeterminate Western blot result in certain situations.
* Polymerase chain reaction (PCR): A specialized blood test that looks for HIV genetic information. Although expensive and labor-intensive, the test can detect the virus even in someone only recently infected.

Typically though if someone tests positive, they retest to see if they get the same result and if that is positive, they follow up with the definitive Western blot. False positives and negatives are a part of testing and it's known so I find it puzzling why a test wasn't repeated on this woman. It makes me suspect this is an urban legend?

[Catbert]

He sounds credible. If you notice, they don't even know if she actually had AIDS or not.

[Melanie68]

Yes but an HIV/AIDS specialist wouldn't take one positive test as a definitive HIV diagnosis. I would think he would retest her to make sure. That's just my take on it.

[Catbert]

But the point is they used her to test a drug. Now they don't know if she actually had AIDS because the diagnostic can hardly be trusted, what with what ensued with the liver complications. That whole story of AIDS overtaking her body so quickly didn't convince me or the journalist, apparently.

[Spiwak]

I'm sorry, I'm with Melanie. I don't believe for a second that a an HIV-specialist wouldn't have retested her or known about this apparent ability of pregnancy to return false positive results.

If the whole thing is true, then yes it is very sad and I'd wish American healthcare to just blow up. But either there's a lot of incompetence going on or these guys are just incredibly sick. I'm not sure I believe the article, though.

[Catbert]

I'm more inclined to believing this kind of things can be bought into. Doctor's hearts aren't bigger than their pockets. http://harpers.org/HarpersMission.html I don't find it that hard to believe this one business, the one where doing this kind of thing is so easy and part of the game, is innocent of stuff like this.

[Jeysie]

To be honest, when I read the article, all I could think was, "This sounds like the sort of thing you'd read in the plot for a bestseller novel from Robin Cook."

I have to admit I also find it hard to believe that there was no follow-up HIV test done... or that they'd have to fake a positive result to get test subjects when last I knew there's no shortage of people in the US who actually *do* have HIV/AIDS.

Peace & Luv, Liz

[Catbert]

So-called community AIDS activists were sprung like cuckoo birds from grandfather clocks at the appointed hour to affirm the unwavering AIDS cathechism: AIDS drugs save lives. To suggest otherwise is to endanger millions of African babies. Front and center were organizations like the Elizabeth Glaser Pediatric AIDS Foundation, which extolled the importance of nevirapine. Elizabeth Glaser’s nevirapine defenders apparently didn’t encounter a single media professional who knew, or cared, that the organization had received $1 million from nevirapine’s maker, Boehringer Ingelheim, in 2000.[3] This was no scandal but simply part of a landscape. Pharmaceutical companies fund AIDS organizations, which in turn are quoted uncritically in the media about how many lives their drugs save. This time the AIDS organizations were joined by none other than the White House, which was in the midst of promoting a major program to make nevirapine available across Africa.

And stuff like this doesn't make your nose twitch? It sure makes mine. Don't get me wrong, I respect scepticism, but the person that passed this link unto me is to be trusted. And also I hate doctors and their... their music.

[Jeysie]

Originally Posted by Catbert

Don't get me wrong, I respect scepticism, but the person that passed this link unto me is to be trusted. And also I hate doctors and their... their music.

I have people I trust... and they still sometimes send me stuff that, say, the Urban Legends Reference Pages debunked a long time ago, because they don't know any better.

And, why hate doctors? There's bad apples in every bunch, but most doctors are people who worked hard for many years to learn how to heal people. My mom used to be a nurse's aid... I spent most of my childhood more than passingly familiar with hospital environments.

I'm not going to say there ain't a lot of crap coming from the FDA's direction (Thalidomide, anyone? Or fen-phen?)... but mass conspiracies where doctors fake test results to use dangerous drugs on people who aren't sick? Like I said, it sounds like a pulp medical thriller.

Peace & Luv, Liz

[Stoofa]

Originally Posted by Jeysie

I'm not going to say there ain't a lot of crap coming from the FDA's direction (Thalidomide, anyone? Or fen-phen?)... but mass conspiracies where doctors fake test results to use dangerous drugs on people who aren't sick? Like I said, it sounds like a pulp medical thriller.

The principal investigator may not have faked the results, but he may have been so eager to get study participants that he did not follow procedure properly. Deceiving clinical trial participants and not treating them with due care is common. It might not result in death, and it might not make Harper's Bizarre, but it does happen regularly. These studies typically attract the poor and the under-educated who do not clearly understand the risks of taking part in the trial and desperately need the money, this makes it very easy to take advantage of clinical trial participants.

The Tuskegee Syphilis study was run for 40 years, starting in 1932, and was only terminated because of bad press. Thanks to the Tuskegee Study and the Willowbrook Hepatitis Studies the U.S. now has IRBs (Institutional Review Boards, also called Research Ethics Boards in Canada), who must follow FDA regulations when monitoring clinical trials of FDA regulated products (i.e, drugs), but IRBs are not closely monitored by the FDA. IRBs are often funded by pharmaceutical companies, the same pharmaceutical companies running the clinical trials of new drugs. If you wanted to you could found your own IRB to monitor your own clinical trial. No wonder ethical breaches happen.

(WIRB is the most notorious and the largest of review boards if you're curious and want to read more about IRBs.)

Ever wonder how in the world would a drug like Vioxx get approved? Merck's own studies showed that it increased the risk of heart attack fivefold. Merck did manipulate the data, but the FDA sat by and twiddled its thumbs while people were dying.

The FDA is partially funded by drug companies now, something a lot of people aren't aware of. When AIDS activists were pushing for AIDS drugs to be pushed through the approval process more quickly it opened the door for the FDA to start charging drug companies fees to get their drugs approved quickly. The pharmaceutical industry is incredibly profitable. They are ruthless businesses, they do not care about curing disease, their primary directive is to get blockbuster drugs approved and to make obscene amounts of money. Prilosec topped $6 billion in profits a year. That BLOWS MY MIND.

I'm going to stop now before I get carried away and bore you all. I have a huge interest in the FDA, clinical trials, REBs/IRBs and especially Big Pharma. Many people do not understand just how underhanded and ethically questionable Big Pharma is. They sell the disease, then the drug. Drug company reps give money and gifts to pharmacists and physicians (who are referred to as "script writers" because to Big Pharma that's all doctors are). Drug companies will even ghostwrite articles about their star drugs and pay a doctor to sign the article to give it more credibility. Medical schools receive huge amounts of money from drug companies, drug companies start wooing doctors before they've even gotten their MDs. It all really gives me a bad feeling.

[jjacob]

The pharmaceutical industrial complex is no better than the military- or prison industrial complex, but this is just a freak accident, not some twisted act of malice (though those trials do reak of incompetence and cash politics, I mean, a maximum bearable toxicity test on pregnant women? Bloody hell). It's a sad series of events leading to an unnecessary death

[Catbert]

I think the point is liver failure death from AIDS drugs is very common, that AIDS drugs aren't that miraculous: they kill you.

[Sage]

Originally Posted by Catbert

I think the point is liver failure death from AIDS drugs is very common, that AIDS drugs aren't that miraculous: they kill you.

That's a rather irresponsible and uninformed statement. I have known a whole bunch of people who died from AIDS back during the days when no treatments were available, and I also know a whole bunch of people with AIDS who are alive today because they were diagnosed and began a successful drug regimen. HIV mutates very quickly, and not all drugs (or combinations thereof) are effective on all patients, and sometimes a trial-and-error process is necessary to determine which drugs are most effective on each individual patient.
I have known of people with AIDS to die of every opportunistic infection you can imagine, but I have never heard of a single one dying of liver failure caused by their medication except for the person in the article you quoted. She was in a trial to determine maximum allowable toxicity levels, and clearly the level to which she was subjected was too high. She displayed textbook symptoms of liver disease/failure, and her doctor should have taken her off the trial immediately upon seeing these.
Was her doctor irresponsible? If the article is a complete and accurate account...yes. Was her death the fault of the drugs she was given? No, it was the fault of the amounts of the drugs she was given, and her doctor's inattention to her symptoms and complaints.
Penicillin is a "wonder drug" and can cure a vast array of infections, but to a person who is allergic to penicillin it is a deadly poison. This doesn't mean penicillin shouldn't be given to the great percentage of people who can tolerate it, and who will benefit from it.

[Intrepid Homoludens]

Originally Posted by Catbert

I think the point is liver failure death from AIDS drugs is very common, that AIDS drugs aren't that miraculous: they kill you.

Catbert, I was to reply to this post but Scottsie pretty much summed up what I was going to state. I too know people who have either died of complications of AIDS or are living with HIV and are doing very well because of the medicinal regimen they're on and their decided effort to live as healthily as they can.

You exhibited ignorance with that statement. Many antiretroviral drugs and other drugs related to combatting AIDS are not much different from other kinds of medicines to treat various kinds of illnesses - overdosing on them or allergic reactions to them or other factors can contribute to nasty reactions or even death from people taking them. They're not that different, really, from medicines like Vioxx or Ambien. There can be weird side effects, but that's the nature of many drugs. You have to take into account many logistical details before deciding whether to suggest this or that killed the person.

[Catbert]

http://www.healtoronto.com/justice_liver.html

"Our study shows that even patients whose elevations are mild to moderate have a death rate that is nearly twice that of patients with mid-range normal levels. This association with increased mortality suggests that any elevation in ALT and AST should be addressed."

Elevations in these enzymes signal injury to liver cells and, in some cases, to other cells in the body. The condition can result from highly active anti-retroviral therapy (HAART), viral hepatitis or alcohol abuse, all of which are toxic to liver cells. Liver failure is the most common cause of death in people with AIDS.

[Intrepid Homoludens]

Catbert, may I ask..........why are you so interested in this?

[Catbert]

I have no idea myself. I don't have AIDS, if that's the implied question.